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06082025GUDIDSync2.001

FDA UDI

Class II (US FDA UDI)

by Newclip Technics

Identity

Trade Name
06082025GUDIDSync2.001 FDA UDI
Generic Name
Vimentin IVD, calibrator FDA UDI
Model / Reference
06082025GUDIDSync2 FDA UDI

Identifiers

Primary DI / UDI-DI
03400420000050 FDA UDI
FDA Product Code
FRT FDA UDI
GMDN Term
Vimentin IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Chlorine Dioxide FDA UDI

Category: Vimentin IVD, calibrator

06082025GUDIDSync2.001 by Newclip Technics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vimentin IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Newclip Technics

Sources (1)

  • FDA UDI f0950ea1-d82d-4601-bb4f-eb9f2f9e7033 32 fields · synced May 31, 2026